Prehospital ECPR in Moravia Silesia Region

NCT07041086 | Recruiting

• 1 other identifier: FNO-KARIM-01-Pain
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.

Conditions

Cardiac Arrest, Out-Of-Hospital

Keywords

ECMO; Cardiac arrest; Cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (6)

• Time from cardiac arrest (collapse) to implantation of ECMO

  The time from cardiac arrest (collapse) to implantation of ECMO will be recorded and assessed

  up to 60 minutes

• Hospital mortality

  Hospital mortality will be assessed for the period of 3 weeks

  up to 3 weeks

• Cerebral Performance Category (CPC) score

  Cerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest

  30 days

• Neurological outcome (CPC score)

  Neurological outcome will be assessed using the Cerebral Performance Category Scale (CPC) 6 months after cardiac arrest.

  6 months

• Neurological outcome (SF-36)

  Neurological outcome will be assessed using the Short Form 36 Health Subject Questionnaire (SF-36) 6 months after cardiac arrest.

  6 months

• Neurological outcome (EQ-5D)

  Neurological outcome will be assessed using the European Quality of Life Questionnaire (EQ-5D) 6 months after cardiac arrest.

  6 months

Study Arms (1)

Out-of-hospital cardiac arrest on ECMO

Patients with out-of-hospital cardiac arrest indicated for ECMO

Procedure: Extracorporeal membrane oxygenation (ECMO)

Interventions

Extracorporeal membrane oxygenation (ECMO) PROCEDURE

In extracorporeal membrane oxygenation (ECMO), blood is pumped outside of the body to a heart-lung machine. The machine removes carbon dioxide and sends oxygen-rich blood back to the body. Blood flows from the right side of the heart to the heart-lung machine. It's then rewarmed and sent back to the body.

Out-of-hospital cardiac arrest on ECMO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after out-of-hospital cardiac arrest

You may qualify if:

• Age ≥ 18 years
• Observed collapse and presumption of cardiac cause of cardiac arrest
• Estimated age up to 70 years
• Baseline rhythm of ventricular fibrillation or pulseless electrical activity (PEA)
• Basic bystander cardiopulmonary resuscitation (CPR), "bystander CPR", telephone assisted CPR (TANR)

You may not qualify if:

• Children or adults with estimated weight below 40 kg
• Known major comorbidities of the patient suggesting low rehabilitation potential (e.g. chronic obstructive pulmonary disease (COPD) IV, malignancy in tertiary phase)

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Emergency Medical Services, Moravian-Silesian Region: collaborator

Study Sites (2)

Emergency Medical Services, Moravian-Silesian Region

Ostrava, Moravian-Silesian Region, 700 30, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Filip Burša, MD, PhD, EDEC

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 27, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)